Phase 3 N=792 Randomized Treatment

ODYSSEY (PENTA 20)

HIV Infection

Bottom Line

View on ClinicalTrials.gov: NCT02259127 ↗

Enrolled (actual)

792

Serious AEs

11.5%

Results posted

Jul 2025

Primary outcome: Primary: Difference in Proportion With Failure (Clinical or Virological) — 0; 3; 0; 0 Participants — p== 0.004

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Dolutegravir (Drug); Standard of Care (Drug)
Age: Pediatric, Adult · 0+ yrs
Sex: All
Sponsor: PENTA Foundation
Primary completion: Mar 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Difference in Proportion With Failure (Clinical or Virological)	0; 3; 0; 0; 0; 2	= 0.004 sig
SECONDARY HIV-1 RNA <50c/ml at 96 Weeks	270; 252; 27; 19; 117; 113	= 0.1377
SECONDARY HIV-1 RNA <400c/mL at 96 Weeks	299; 285; 33; 26; 129; 124	= 0.2256
SECONDARY Mean Change in CD4 Count From Baseline to Week 96	265; 230; 72; 51; 311; 267	= 0.144
SECONDARY Mean Change in Total Cholesterol From Baseline to Week 96	-5.0; 9.9; 4.5; 29.6; 2.1; 19.6	< 0.001 sig
SECONDARY Serious Adverse Events	35; 40; 11; 11; 23; 27	= 0.53
SECONDARY Grade 3 or Above Clinical and Laboratory Adverse Events	73; 86; 19; 21; 48; 43	= 0.24
SECONDARY Adverse Events Leading to ART Modification Any Grade	5; 17; 0; 2; 3; 8	= 0.01 sig
SECONDARY Treatment Failure by 48 Weeks	0; 3; 0; 0; 0; 2	= 0.003 sig
SECONDARY Treatment Failure by 144 Weeks	0; 3; 0; 2; 0; 1	= 0.003 sig
SECONDARY WHO 4, Severe WHO 3 Events and Death	8; 8; 3; 6; 6; 6	= 0.993
SECONDARY Per Protocol: Treatment Failure by 96 Weeks	44; 62; 12; 20; 13; 28	= 0.015 sig
SECONDARY Any Drug Class Resistance After Virologic Failure	0; 28; 23; 36; 6; 12	—
SECONDARY NRTI Resistance After Virologic Failure	0; 18; 21; 31; 1; 10	—
SECONDARY NNRTI Resistance After Virologic Failure	0; 27; 22; 36; 6; 11	—
SECONDARY PI Resistance After Virologic Failure	0; 0; 2; 3; 0; 2	—
SECONDARY INSTI Resistance After Virologic Failure	0; 4; 0; 1	—
SECONDARY Emerging Resistance to Any Drug Class After Virologic Failure	97; 22; 19; 0; 100; 50	—
SECONDARY NRTI Emerging Resistance After Virologic Failure	62; 8; 10; 100; 100	—
SECONDARY NNRTI Emerging Resistance After Virologic Failure	88; 100	—
SECONDARY PI Emerging Resistance After Virologic Failure	5; 100	—
SECONDARY INSTI Emerging Resistance After Virologic Failure	18; 0; 50	—
SECONDARY Time to Any New or Recurrent AIDS Defining Event (WHO 4) or Severe WHO 3 Events	—	—
SECONDARY Adherence Questionnaire	—	—
SECONDARY Health-related Quality of Life Questionnaire	—	—
SECONDARY Acceptability Questionnaire	—	—

Summary

A new anti-HIV medicine (Dolutegravir) combined with 2 currently used anti-HIV medicines is non-inferior to the standard combination of medicines used in terms of efficacy and better in terms of toxicity.

Eligibility Criteria

Inclusion Criteria

ALL PATIENTS:

Children ≥28 days and <18 years weighing ≥3kg with confirmed HIV-1 infection
Parents/carers and children, where applicable, give informed written consent
Girls aged 12 years or older who have reached menses must have a negative pregnancy test at screening and be willing to adhere to effective methods of contraception if sexually active
Children with co-infections who need to start ART can be enrolled into ODYSSEY according to local/national guidelines
Parents/carers and children, where applicable, willing to adhere to a minimum of 96 weeks' follow-up
Children weighing 3 to <14kg must be eligible and willing to participate in the Weight band (WB)-Pharmacokinetics (PK)1 substudy unless direct enrolment for the child's weight band has opened following the WB-PK1 substudy and/or dosing information has become available from the IMPAACT P1093 DTG dose-finding study.

ADDITIONAL CRITERIA FOR ODYSSEY A:

Planning to start first-line ART

ADDITIONAL CRITERIA FOR ODYSSEY B:

Planning to start second-line ART defined as either: (i) switch of at least 2 ART drugs due to treatment failure; or (ii) switch of only the third agent due to treatment failure where drug sensitivity tests show no mutations conferring Nucleoside Reverse Transcriptase Inhibitor (NRTI) resistance
Treated with only one previous ART regimen. Single drug substitutions for toxicity, simplification, changes in national guidelines or drug availability are allowed
At least one NRTI with predicted preserved activity available for a background regimen
In settings where resistance tests are routinely available, at least one new active NRTI from tenofovir disoproxil fumarate, abacavir or zidovudine should have preserved activity based on cumulative results of resistance tests
In settings where resistance tests are not routinely available, children who are due to switch according to national guidelines should have at least one new NRTI predicted to be available from tenofovir disoproxil fumarate, abacavir or zidovudine
Viral load ≥ 500 c/ml at screening visit

Exclusion Criteria

History or presence of known allergy or contraindications to dolutegravir
History or presence of known allergy or contraindications to proposed available NRTI backbone or proposed available SOC third agent.
Alanine aminotransferase (ALT) ≥ 5 times the upper limit of normal, OR ALT ≥3x upper limit of normal and bilirubin ≥2x upper limit of normal
Patients with severe hepatic impairment or unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
Anticipated need for Hepatitis C virus (HCV) therapy during the study
Pregnancy or breastfeeding
Evidence of lack of susceptibility to integrase inhibitors or more than a 2-week exposure to antiretrovirals of this class

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02259127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.